Clearance Summary
ORTHODONTIC BUCCAL TUBE received FDA 510(k) clearance under submission number K780205, sponsored by Rocky Mountain Orthodontics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-02-16.
- Submission: K780205
- Applicant / Sponsor: Rocky Mountain Orthodontics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1978-02-16
Classification & Regulation
This clearance is catalogued under FDA product code DZD and 21 CFR 872.5410, within the Dental review panel as a Class I device.